Elelyso, a Pfizer therapy for Type 1 Gaucher disease, has just become the first ever prescription medication to receive a kosher certification—even though it didn't need one.
The medication is a form or enzyme replacement therapy for the long-term treatment of adults with the disease, for which one in every 14 Ashkenazi Jews is a carrier, according to the National Human Genome Research Institute. The Orthodox Union, an American Jewish organization that provides the circled-U "Ⓤ" symbol to food products, certified Elelyso's manufacturing facility in Israel operated by Protalix Biotherapeutics, according to a Pfizer press release.
The kosher criteria were "met due to Protalix's innovative and proprietary manufacturing system, which uses genetically engineered carrot cells grown in a simple solution of water, plant extracts, sugar and a mixture of vitamins and minerals," according to the press release.
Even the most stringent kosher rules allow for any therapy to be used in deadly circumstances, and technically never govern non-oral medications (Elelyso is injected), but a Pfizer spokeswoman told CNBC the certification "shows Pfizer's commitment to the Gaucher disease community."
"In a life or death situation, Jewish law clearly sets aside the kosher status of a prescription medicine, but in other cases, it is preferable and sometimes recommended that a medicine be certified kosher," Rabbi Menachem Genack, the CEO of OU Kosher, said in the Pfizer release. "We commend Pfizer for taking this step and making this commitment to the Jewish community."
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Pfizer paid OU a "nominal fee" to cover expenses related to the facility inspection, and to obtain the certification, the Pfizer spokeswoman said.
Pfizer and Protalix's medication became the third Gaucher drug to come to the market when it was approved by the FDA in 2012. Although Shire's Vpriv and Sanofi's Cerezyme came out before Elelyso, analysts told Reuters that a lower price coupled with Pfizer's marketing skills would gain it a large share of the market (estimated to be worth $4.5 billion by 2016).
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Requests for comment from Shire and Sanofi were not immediately returned.
Gaucher disease prevents the breakdown of some fats because of an enzyme deficiency and may lead to organ damage or even death. Type 1 Gaucher is thought to affect about 6,000 people in the United States, and it is the most common genetic disorder in people with Ashkenazic Jewish ancestry, according to the National Gaucher foundation.
—By CNBC's Everett Rosenfeld.